Rfid dose tracking mechanism for injection devices

ABSTRACT

Described is a dose tracking mechanism for a drug delivery device, including an RFID device with an electric circuit and a switch operable to open and close the electric circuit to transmit a wireless signal to a receiving device when the electric circuit is closed by the switch. The switch is configured to open and close in response to operation of a dose setting and/or a dose dispensing mechanism of the drug delivery device, and the closing and opening of the electric circuit generates a pulse of the wireless RFID signal. In one embodiment, each pulse corresponds to a unit of a dose of medicament set by the dose setting mechanism or dispensed by the dose dispensing mechanism from a drug container of the drug delivery device, depending on if the dose setting or dose dispensing mechanism is arranged to toggle the switch.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is the national stage entry of InternationalPatent Application No. PCT/EP2018/085395, filed on Dec. 18, 2018, andclaims priority to Application No. EP 17306864.4, filed on Dec. 21,2017, the entire disclosures of which are incorporated herein byreference.

TECHNICAL FIELD

This disclosure relates to a dose tracking mechanism for generatingpulses of an RFID signal to track the amount of a dose delivered from adrug delivery device.

BACKGROUND

A variety of diseases can be treated by injection of a medicament. Suchinjections can be performed using drug delivery devices, which can beapplied either by medical personnel or by patients themselves. As anexample, type-1 and type-2 diabetes can be treated by patientsthemselves by injection of drug doses, for example once or several timesper day. For instance, a pre-filled disposable drug pen or autoinjectorcan be used as a drug delivery device. Alternatively, a re-usable pen orautoinjector may be used. A re-usable pen or autoinjector allowsreplacement of an empty medicament cartridge (or any other kind ofmedicament container) by a new one. Either type of pen or autoinjectormay come with a set of one-way needles that are replaced before eachuse. The medicament dose may vary individually, therefore a user (e.g.,a patient or health care professional) may select the amount ofmedicament required (e.g. dial a dose) by operating a dose settingmechanism of the drug delivery device prior to use.

SUMMARY

This disclosure relates to drug delivery devices having RFID electronicscapable of being switched on and off (i.e., pulsed) in order to track aset or delivered dose of a medicament from the drug delivery device.This principle is based on using an RFID chip, which typically includesa memory and an antenna formed by an electric circuit. In operation,when the RFID chip is in the reach of a reader device such as a smartphone with an RFID reader, the antenna receives a signal from the smartphone and sends a wireless response signal according to the informationencoded in the memory of the chip. In a representative example, theelectric circuit of the antenna is open in a default state and is closed(e.g., completing the circuit and enabling the antenna to transmit theresponse signal) in synchronization with the movements of a dose settingor dispensing operating of the drug delivery device. In this manner,repetitive opening and closing of the RFID antenna results in acountably pulses of the wireless response signal (i.e., an RFID signal),which are synchronized such that the number of pulses indicates anamount of movement of a dose setting or dose dispensing mechanism of thedrug delivery device. Where, for example, if 10 units of a medicament isdelivered from a drug delivery device with a corresponding movement of adose delivery mechanism, 10 pulses of the RFID signal are created.Aspects of this system can be implemented in a drug delivery device in anumber of ways. In one example, a mechanical clicker is configured tooperate the closing of the circuit of the antenna at each click, where adose delivery mechanism is arranged to actuate the clicker during a dosedelivery operation. Thus, the RFID signal is sent in a pulsed manner,where the number of pulses is proportional to the number of clicks, andwhere the mechanical clicker and dose delivery mechanism are arrangedsuch that the number of clicks represents an amount of medicament thatis dispensed. Finally, an external device counts the number of detectedRFID pulses and computes the amount of medicament delivered during thedose dispensing operation.

In addition, a medicament and/or dose information can be transmittedwith the encoded information of the RFID chip. In some instances, thismay be only a unique tag serial number, or may be product-relatedinformation such as a stock number, lot or batch number, productiondate, or other specific information. Because RFID chips can haveindividual serial numbers, aspects of the present RFID trackingmechanism can discriminate among several tags that might be within therange of the RFID reader (i.e., an external device) and read severaltags simultaneously. In this manner, it can be ensured that only thecorrect device is interrogated and the respective response is capturedby the RFID reader.

Certain aspects of the present disclosure result in several advantagesbeyond the ability to easily track a set and/or dispensed dose from adrug delivery device. For example, a drug delivery device often includesa serial, stock, batch number, or production date in addition toinformation regarding the medicament, such as expiration, drug name,drug type, and concentration. Because an RFID chip is able to storespecific data stored in a local memory, including any of theaforementioned information, and transmit this data in the RFID signalitself. This data can also be centrally tracked by the manufacturer toassist in recalls, track and analyze patient behavior, and monitorproduct usage. The use of a passive RFID chip has the advantage of beingsimple, reliable, and cost-effective. Additionally, with existing drugdelivery devices, there are only minor modifications required to thedose delivery or setting mechanism to integrate the RFID chip, due tothe small size and thickness of typical RFID chips. For example, anexisting pen injector with a feedback clicker only needs to have an RFIDchip and switch into the housing such that the switch in the electroniccircuit that is operated by the existing feedback clicker. Optionally,the clicker itself can be modified to serve as a switch.

An example embodiment of the present disclosure is a drug deliverydevice having a dose tracking mechanism including a housing and an RFIDdevice. The RFID device includes an electric circuit including anantenna and a switch operable to open and close the electric circuit,where the antenna is configured to transmit a wireless signal to areceiving device when the electric circuit is closed by the switch. Theswitch is configured to open and close in response to operation of adose setting mechanism of the drug delivery device to set a dose of amedicament and/or a dose dispensing mechanism of the drug deliverydevice to dispense a dose of medicament. Closing and opening of theelectric circuit generates a pulse of the wireless signal the pulse isusable to identify a quantity of medicament administered by the drugdelivery device.

In some instances, the switch is configured to close and subsequentlyopen the electric circuit periodically during a dose setting operationto set the dose and/or a dose dispensing operation to dispense to dose.

In some instances, each pulse corresponds to an amount of the medicamentset by the dose setting mechanism and/or dispensed by the dosedispensing mechanism such that a total number of pulses indicates atotal amount of the medicament.

In some instances, the switch is operationally coupled to a clickermechanism, where the clicker mechanism is operated during the dosesetting operation and/or the dose dispensing operation.

In some instances, the clicker mechanism includes a feedback mechanismconfigured to produce an audible or tactile feedback during the dosesetting operation or the dose delivery operation, and where the switcharranged to be actuated by the feedback mechanism.

In some instances, the switch is integrally formed with the clickermechanism.

In some instances, the dose setting mechanism or the dose dispensingmechanism includes a one or more actuation features configured to engagethe switch of the RFID device in succession during the dose settingoperation or the dose dispensing operation such that the switch closesand subsequently opens the electric circuit to generate one pulse foreach of the one or more of actuation features that engaged the switch.

In some instances, the dose setting mechanism is configured to moveproportionally to the dose set during the dose setting operation and/orthe dose dispensing mechanism is configured to move proportionally tothe dose dispensed during the dose dispensing operation, and where theone or more actuation features are configured to operate the switch suchthat the switch generates one pulse for each step of movement of thedose setting mechanism and/or the dose dispensing mechanism such that anumber of the pulses indicates the amount of the dose set or dispensed.

In some instances, the dose setting mechanism includes a dose dialsleeve configured to rotate helically with respect to the housing.

In some instances, dose dial sleeve includes one or more actuationfeatures configured to engage the switch, each of the one or more ofactuation features corresponding to a set dose indicated by the dosedial sleeve during the dose setting operation.

In some instances, the dose dispensing mechanism includes a piston rodconfigured to move with respect to the housing during a dose dispensingoperation, and where the dose dispensing mechanism includes the one ormore actuation features configured to engage the switch, each of the oneor more of actuation features corresponding to an amount of movement ofthe piston rod.

In some instances, the RFID device is a passive RFID device configuredto transmit the wireless signal when RF energy is received from anexternal RFID reader.

In some instances, the dose tracking mechanism includes a power source,and where the RFID device is an active RFID device configured to receivepower from the power source and to transmit the wireless signal usingthe received power when the switch closes the electric circuit.

In some instances, the wireless signal includes identificationinformation related to the drug delivery device or a medicamentcontained therein.

Another example of the present disclosure is a method for wirelesslytracking an indication of a dose injected by a drug delivery device. Themethod includes opening and then closing an electric circuit of an RFIDdevice once for each unit of movement of a dose dispensing mechanism ofthe drug delivery device during a dose dispensing operation or for eachunit of movement of a dose setting mechanism of the drug delivery deviceduring a dose setting operation by toggling a switch in the electriccircuit and transmitting a pulse of a wireless signal via an antenna ofthe RFID device for each closing of the electric circuit, the RFIDdevice transmitting a number of pulses proportional to a quantity of adose of medicament set during the dose setting operation or dispensedduring the dose dispensing operation.

In some instances, the wireless signal includes information a medicamentdelivered by the dose dispensing mechanism during the dose dispensingoperation and/or the drug delivery device, where the information issufficient to enable calculation of the amount of medicament that hasbeen delivered by the drug delivery device based on the number of pulsestransmitted.

In some instances, the method includes receiving an RF energy from anexternal device with the antenna of the electric circuit andtransmitting the wireless signal with the antenna of the RFID deviceusing the received RF energy.

In some instances, the method includes receiving electric energy from aninternal power storage device with the RFID device when the electriccircuit is closed and transmitting the wireless signal with the antennaof the RFID device using the received electric energy.

In some instances, the dose dial is a dose dial sleeve, and where movingthe dose dial sleeve one unit for each unit of the dose includingrotating the dose dial sleeve with respect to a housing of the drugdelivery device.

In some instances, rotating the dose dial sleeve with respect to ahousing of the drug delivery device including moving the dose dialsleeve helically with respect to the housing.

In some instances, moving the dose dial one unit includes engaging anddisengaging an actuation feature of the dose dial with the switch toopen and close the switch.

In some instances, the method includes producing an audible or tactilefeedback for each unit of movement of the dose dial.

In some instances, the opening and the closing of the switch operating afeedback mechanism producing the audible or tactile feedback for eachunit of movement of the dose dial.

In some instances, the wireless signal includes identificationinformation related to the drug delivery device or a medicamentcontained therein.

In some instances, the RFID transmits the wireless signal at a firstfrequency in response to the movement of the dose dial, and the methodincludes opening and then closing a second switch of the electriccircuit of the RFID device when a trigger button of the drug deliverydevice is activated and transmitting the wireless signal at a secondfrequency when the second switch closes the electric circuit.

Yet another example is a method for wirelessly transmitting anindication of a dose of a medicament delivered by a drug deliverydevice. The method includes moving a dose setting mechanism of the drugdelivery device to set the dose, actuating a drug dispensing mechanism,the drug dispensing mechanism moving one unit for each unit of the dose,the moving of the dose dispensing mechanism opening and then closing aswitch of an electric circuit of an RFID device once for each unit ofmovement of the dose dispensing mechanism, the RFID device transmittinga wireless signal when the electric circuit is closed such that the RFIDdevice pulses the transmission of the wireless signal with a number ofpulses equal to the units of the dose, receiving the indication of thedose by receiving and counting the pulses of the wireless signal fromthe RFID device with an external device, and deriving an amount of themedicament delivered by counting the number of pulses.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A is an exploded view of a drug delivery device.

FIG. 1B is a cross sectional view of a portion of the drug deliverydevice of FIG. 1A.

FIG. 2A and 2B are illustration of a dose dial sleeve and clicker,respectively.

FIG. 3 is an illustration of an RFID circuit.

FIG. 4 is a schematic of the operation of a switched RFID electroniccircuit.

FIG. 5 is a graph of the RFID signal over time during a dose dispensingoperation.

FIG. 6 is an illustration of the clicker assembly of the drug deliverydevice.

DETAILED DESCRIPTION

Cartridge-based injection and medical syringe systems can includeintegrated electronics that enable detection of a dose set by the user,or a measurement of the medicament delivered by the device (e.g., aposition sensor), along with some feature for presenting thisinformation to the user. For example, a digital display arranged todisplay a dose or a wireless connection to transmit the dose data.However, the above examples typically require an internal source ofpower, either to run the sensor(s) or the wireless transmission. Certainaspects of the present disclosure provide a drug delivery device with adose tracking mechanism generating a wireless RFID signal that encodesone or more of a dose set and a dose delivered by the drug deliverydevice without the need for an internal power source. Certain aspectsalso relate to a dose tracking mechanism that generates the wirelessRFID signal using an active (e.g., battery powered) RFID transmitter. Incertain aspects, a switch is provided in the drug delivery device toclose a close a circuit of an RFID chip, such that the dose trackingmechanism transmits a pulse of an RFID signal each time the circuitcloses. In some example, the switch is provided as an addition componentof a drug delivery device. In another example, the switch is operated bya clicker or feedback mechanism of the drug delivery device. In yetanother example, the switch in integrated into the clicker or feedbackmechanism.

In a representative embodiment, an RFID circuit in a drug deliverydevice includes a switch that opens and closes multiple times during themovement of a dose setting operation or a dose delivery operation. Eachclosing of the switch completes the RFID circuit such that the RFIDcircuit is able to transmit a wireless signal in response to a receivedsignal only with the switch closing the circuit. In operation, thereceived signal is transmitted from some external device, such as asmart phone or an RFID reader, and the RFID circuit of the drug deliverydevice transmits a pulse of the RFID signal each time the switch closesthe RFID circuit. In this manner, for example, during a drug deliveryoperation, a dose dispensing mechanism moves an amount corresponding tothe amount of medicament delivered. During this movement, the dosedispending mechanism repeatedly actuates the switch, which closes theRFID circuit a number of times corresponding to the amount of medicamentdelivered. Finally, because this closing of the switch completes theRFID circuit, a number of pulses of the RFID signal are generated (inresponse to a received signal during the dose delivery operation). Thenumber of pulses are then easily counted by an external device, and theamount of medicament delivered is determined based on a knownrelationship between the movement of the dose dispensing mechanism(e.g., the number of pulses) and an amount of medicament delivered foreach pulse. In an alternative configuration, the switch is nominallyclosed, and opens during the dose dispensing or dose setting operationsuch that pulses generated are the inverse of the earlier configuration,and there resultant gaps in the signal are counted to determine theamount of medicament delivered, or the dose set.

While the above description includes a passive RFID system (i.e., nointernal power source), passive RFID signals are often limited in thistransmission distance. Alternatively, an active RFID chip could be used,where active RFID chips are generally understood to require a source ofpower beyond any received RF energy in order to generate the wirelessresponse signal with more power. The design is similar in functioncompared to the above passive system, with the addition of a battery toboost the transmission power of the RFID signal. The power is onlyrequired to feed the system when in use. In some examples, an air-zincbattery is used to ensure that the drug delivery device is disposable,if necessary. In this instance, the air-zinc battery is arranged suchthat a protective latch is removed automatically when using the drugdelivery device the first time at dial up. In some instances, thebattery is located in the dose release button and the latch is fixed toa pen housing. Then the RFID chip is ready, but does not initiallytransmit the RFID signal, as the circuit is open in default state, asmentioned above. In some instances, the switch is integrated with anexisting clicker that provides a tactile or audible feedback of theoperation, and, during a dose dispense operation, the switch is closedsynchronously to the clicker noise, and thus the RFID signal is pulsed.In the active RFID system, similar to the passive system, an externaldevice counts the number of pulses and computes the amount of medicamentfrom that. In some instances, the actual data that is being sent fromthe RFID chip in the wireless signal comprises information on themedicament/device and this can be by the reader to interpret the data.For example, the external device can assign the captured number ofpulses to the “right” device and store it appropriately in a separatestorage for this device/medicament.

FIG. 1A is an exploded view of a drug delivery device 100, which may bea disposable or reusable drug delivery device. The drug delivery device100 includes a housing 201, covered by a replaceable cap 299, where thehousing 201 contains a cartridge 214 and a cartridge housing 224 inwhich the cartridge 214 is disposed. A stopper 204 is disposed in thebody of the cartridge 214 and can be advanced within the cartridge 214during use to expel medicament from the cartridge 214. A needle assemblycan be affixed to the cartridge housing 224 or the cartridge 114 todeliver the medicament. To drive the stopper 204 into the cartridge 214,the drug delivery device 100 includes a piston rod 210, a drive sleeve220, and a trigger button 202 (e.g., a dose dispensing mechanism 20),which act together to drive a pressure plate 207 against the stopper 204and into the cartridge 214. A medicament or drug dose to be ejected fromthe drug delivery device 100 is selected by turning a dosage knob 203,which is connected by a threaded insert 205 a dose dial sleeve 230,where rotation of the dose dial sleeve 230 by the dosage knob 203 causesthe selected dose to be displayed in a dosage window 209 in the housing201 and causes a clicker 250 to interact with the drive sleeve 220 via aspring clutch 206. Together, the dosage knob 203, dose dial sleeve 230,and clicker 250 are a dose setting mechanism 10. The dose dial sleeve230 is arranged around a clicker 250, which includes a feedbackmechanism 251 that generates a tactile or audible feedback with rotationof the dose dial sleeve 230. The clicker 250 is coupled to the drivesleeve 220 with a metal clutch spring 206, and a last dose nut 240 isprovided on the drive sleeve 220. The last dose nut 240 advances witheach dose dispensing operation to track the total medicament remainingin the cartridge 214. Finally, an injection button 202 is included, anddepression injection button 202 activates a dose dispensing operation ofthe drug delivery device 100.

While the dose setting mechanism 10 is illustrated as the dosage knob203, dose dial sleeve 230, and the clicker 250, as described above, oneskilled in the art will appreciate that any number of different dosesetting mechanisms are route in the art for the purposes of setting adose of a drug delivery device and aspects of the present disclosure arecompatible with other such dose setting mechanisms. Similarly, while thedose dispensing mechanism 20 is illustrated as a includes the piston rod210, drive sleeve 220, trigger button 202, one skilled in the art willappreciate that any number of different dose dispensing mechanisms(e.g., drive mechanisms) are route in the art for the purposes ofdelivering or dispensing a dose of a drug delivery device and aspects ofthe present disclosure are compatible with other such dose dispensingmechanisms.

Continuing with the operation of the drug delivery device 100, turningthe dosage knob 203 causes a mechanical click sound to provideacoustical feedback to a user by rotating the dose dial sleeve 230 withrespect to the clicker 250. The numbers displayed in the dosage display209 are printed on the dose dial sleeve 230 that is contained in thehousing 201 and mechanically interacts with the drive sleeve 220 via themetal spring clutch 206 to interact with the cartridge 114. When theinjection button 202 is pushed, the drug dose displayed in the display209 will be ejected from the drug delivery device 100. During a dosesetting operation, the drive sleeve is helically rotated with the dosedial sleeve 230 in the distal direction D. When the injection button 202is pushed, the drive sleeve 220 is released and advanced proximally,which causes rotation of the piston rod 210. The rotation of the pistonrod 210 drives the pressure plate 207 against the stopper 204 of thecartridge 214, which drives the stopper 204 into the cartridge 214 toexpel the medicament from the cartridge 214. A more detailed descriptionof a representative drug delivery device is described in U.S. Pat. No.7,935,088 B2, which is incorporated herein by reference.

FIG. 1B is a cross sectional view of a portion of the drug deliverydevice 100 of FIG. 1A. FIG. 1B shows the drug delivery device 100 at theend of a dose setting operation and prior to a dose dispensingoperation, where the dose dial sleeve 230 and the drive sleeve 220 havebeen helically rotated with respect to the housing 201 and a threadedend 211 of the piston rod 210 to set the dose. The last dose nut 240 isshown advanced along the drive sleeve 220 from an initial position. Uponactivation of the injection button 202, the drive sleeve advances intothe housing 201, and a set of inner threads 241 induce rotation of thepiston rod 210. Rotation of the piston 210 drives the piston rod 210 andthe pressure plate 207 proximally to drive the stopper 204 into thecartridge 214 (FIG. 1A).

FIG. 2A and 2B are illustration of a dose dial sleeve and clicker,respectively. FIG. 2A shows the helical outer thread of the dose dialsleeve 230, and FIG. 2B shows the clicker 250 and feedback mechanism251, where feedback mechanism 251 includes a resilient arm 252configured to be deformed periodically during a dose dispensingoperation of the drug delivery device 100, such that the resilient armproduces a click upon returning to a non-deformed state. The feedbackmechanism is, in some instances, a dispense clicker configured to bemoved over ribs or splines disposed on an inner surface of the dialsleeve 230 during a dose delivery operation. The clicker 250 is, in someinstances, a dose setting clicker, having teeth disposed on the proximalends of the clicker 250, which are configured to engage the metal spring206 during a dose setting operation (e.g., the action when selecting adose size before actually injecting the medicament). In some instances,the metal spring 206 has two splines that engage with ribs at the innersurface of housing part 201 to prevent spring 206 from rotating againsthousing part 201. When setting a dose, sleeves 230 and 250 rotate unisonand as the metal spring 206 does not rotate teeth move over the splinesof the metal spring 206 and produce a click sound. In one example, asshown in U.S. Pat. No. 7,935,088, an inner surface of the housing 201includes splines configured to deflect the resilient arm 252 as theclicker mechanism 250 rotates with respect to the housing 201.

FIG. 3 is an illustration of a passive a RFID circuit 300, which may bea printed RFID circuit. The RFID circuit includes an RFID chip 380 andan antenna 301, where the antenna is coiled around the RFID circuit 300.In operation, the antenna 301 absorbs an incoming wireless reader signalfrom an external device and forms a weak magnetic field, which creates acurrent in the antenna to provide power to the RFID chip 380. The RFIDchip 380 includes a memory, which stores, for example, informationrelated to the drug delivery device 100 or a medicament containedtherein. Upon power being provided to the RFID chip 380, the RFIDgenerates a response signal in the antenna 301, which transmits theinformation from the RFID chip's 380 memory as a wireless signal. Thiswireless signal can be received by the external device that sent thereader signal, or by another device close by.

FIG. 4 is a schematic of the operation of a RFID dose tracking mechanism302 in the drug delivery device 100 further comprising a dose trackingassembly with an RFID device and a switch configured to open and closethe circuitry of the RFID device. The switch is configured to open andclose while the dose setting and/or dose dispensing mechanism isoperated. The RFID dose tracking mechanism 302 includes a RFID circuit300, a switch 370 in the RFID circuit 300, and a resilient arm 252arranged to engage the switch 370 during operation of the drug deliverydevice 100. In some instances, the RFID dose tracking mechanism 302includes a battery 392 configured to provide power to the RFID circuit300 when the switch 370 is engaged, but as described above, the RFIDdose tracking mechanism 302 can also be a passive RFID system, and FIG.4 shows an external device 390 providing a wireless reader signal 391 tothe antenna 301 of the RFID circuit in order to generate power for theRFID chip 380.

In operation, either passive or active, a mechanism of the drug deliverydevice 100 is configured to operate the switch 370 during a dose settingoperation or a dose dispensing operation. For example, FIG. 4 shows aportion of the dose dial sleeve 230 having actuation features 238 thatengage the resilient arm 252 of the clicker during a dose settingoperation (which is shown as movement of the dose dial sleeve in thedirection of arrow 239). Similarly, a component of the dose dispensingmechanism (e.g., the drive sleeve 220) could have actuation featuresarranged to engage the switch 370 during a dose delivery operation. Inboth cases, movement of the dose dispensing mechanism or dose settingmechanism 10 causes the actuation features 238 to engage the resilientarm 252 and deflect it (e.g., position 252′) to operate the switch 370once as each actuation feature passes across the resilient arm 252. Thedose setting and/or the dispensing action may involve rotationalmovement; alternatively, linear movement of a component of the drugdelivery device 100 may also be used to operate the switch.

The switch 370 is configured to open and close the RFID circuit 300,specifically the antenna 301, such that, with the switch 370 open, theantenna 310 does not receive the reader signal 391 or provide power fromthe battery 392 to the RFID chip 380. In some instances, the battery 392is a zinc-air battery. Similarly, with the switch 370 open, the antenna301 does not transmit the response signal 381.

The switch 370 and the RFID antenna 301 are electrically connected viawires. The RFID circuit 300 could be placed on a housing component,preferably as a label (plastic, paper, adhesive RFID chip).Alternatively, the RFID circuit 300 could be located inside the housing201, for example, at the inner surface of the injection button 202 orbetween injection button 202 and another inner component such as thedose dial sleeve 230.

Generally speaking, the switch 370 registers operation of the mechanism(e.g., during a dial and/or dispense operation) and correlates this tomodulate the RFID response signal 381. The modulation is a pulse of,detectable by the external device 390 as, for example, amplitudemodulation of a signal at a specific frequency. When the switch 370 isclosed, the RFID circuit 301 is completed and the response signal 381 istransmitted, which indicates that one toggling of the switch 370occurred, and the actuation features 238 can be configured to generateone pulse of the response signal 381 for any amount of medicament. Thenumber of pulses of the response signal 381 is proportional to theamount of medicament that has been dispensed when the resilient arm 252is actuated by the dose dispensing mechanism. In a more complicatedexample, the number of pulses can also be correlated to the dose thathas been dialed or set. However, in this example, the drug deliverydevice includes a mechanism that can distinguish between up and downdialing and must “know” when a setting operation is ended (e.g., bysensing the start of the dose dispensing operation).

In an alternative dose tracking mechanism 302 configuration, the switch370 is arranged to be contacted or operated by contact by any adjacentcomponents of the drug delivery device 100 that move relative to oneanother during operation (dose setting and/or dose dispensing). Forexample, movement between the dose dial knob 203 and housing 201,between the dose dial sleeve 230 and the window 209, or between the dosedial sleeve 230 and the housing 201. Additionally, more than one clickermechanism 250 may be present, where one is arranged for triggeringduring the dose setting operation, and another is arranged fortriggering during the dose dispensing operation.

FIG. 5 is a graph of the strength 501 of the RFID response signal over381 time 502 during a dose dispensing operation of a drug deliverydevice 100 having the dose tracking mechanism 302. FIG. 5 shows the RFIDresponse signal 381 has an approximately square-wave pattern during dosedispensing operation, where each pulse of the response signal 380corresponds to a time when the switch 370 is closed periodically byactuation features 238 on a component of a dose dispensing mechanism.

Each pulse of the response signal 380 has approximately amplitude 531,and each pulse of the response signal 380 includes the informationstored in the RFID chip 380. The pulses of the response signal 380continue until the end of the dose dispensing operation, at time 521,where 5 pulses of the response signal 380 has occurred. In someinstances, each pulse of the response signal 380 represents a predefinedamount of the medicament dispensed from the drug delivery device 100 bythe dose dispensing mechanism.

FIG. 6 is an illustration of a clicker cylinder assembly of a drugdelivery device 600. FIG. 6 shows another design of the dose trackingmechanism, using electrically conductive components. In FIG. 6, atwo-part clicker cylinder 50, 60 is made from an electrically conductingmaterial or alternatively coated with such a material, e.g., copper,nickel, silver, or gold. The two-part clicker cylinder 50, 60 includesan inner cylinder 50 and an outer cylinder 60. The outer cylinder 60includes a clicker arm 52 that run along the outer surface of innercylinder 50, wherein inner cylinder 50 has ribs or splines.Alternatively, the inner cylinder 50 has teeth on its outer surface thatrun across a resilient rib or arm producing a click sound. Continuing torefer to FIG. 5, a toothed member 54 of the clicker arm 52 is alsofurnished as electrically conducting element, and the clicker arm 52runs along the outer surface of the clicker cylinder 50. When theclicker cylinder 50 rotates relative to the clicker arm 52, click soundsare generated. For each clicker arm 52, a particularly toothed member 54runs along an inclined surface of a longitudinal spline 56 and the fallsdown in a trough between the splines 56, making a click sound. Duringeach fall, there is no contact between toothed member 54 and cylinder 50and thus an electrical contact between the two-part clicker cylinder 50,60 is interrupted. An RFID circuit 300 is in electrical connection withthe two-part clicker cylinder 50, 60 and interrupting the contact leadsto opening the circuit of the RFID chip 380 and thus the RFID responsesignal 381 is pulsed.

In some instances, the clicker arm 52 could additionally be configuredas a switch 370. For example, the tip (outer surface) of toothed member54 could comprise a dome switch, where the dome switch is closed whenthe toothed member 54 runs across the top of the splines 56 of outersurface of cylinder 50. Alternatively, the inner surface of toothedmember 54 could comprise a dome switch. The dome switch is closed whenthe toothed member 54 is pushed radially inwards and about a surfacebefore crossing the top of a spline 56. In other instances, the abuttingsurface (e.g., inner surface of housing 201) carries a dome switch,which is activated upon the toothed member being forced radially outwardtowards the housing 201 when moving across each spline 56.

Aspects of the systems disclose above enable medical injectors to employ‘smart’ technologies by way of an attached of the included electroniccomponents (e.g. RFID, sensor) to give a certain features to a cartridgeof a drug delivery device (e.g. of a pen-type injector). Whenintegrating electronics into drug delivery device, a one or morecomponents may be active (e.g., a sensor to measure certain propertiesof the injector or cartridge) and require an energy source, whichtypically could be a battery. One alternative is to use a means ofenergy harvesting as a power source replacement for a battery.

Embodiments of the present disclosure can also apply to prefilled singleand double chamber syringes that may not use a cartridge. In someinstances, the dose tracking mechanism is contained in the cartridge orin the drug delivery device in a manner enabling the dose trackingmechanism assembly to sense a change in the fill level of the cartridgeor syringe after an injection. In some instances, components of theelectronics assembly are located outside of the cartridge or indifferent parts of the cartridge or drug delivery device.

Some of the features described can be implemented in digital electroniccircuitry, or in computer hardware, firmware, software, or incombinations of them. The apparatus can be implemented in a computerprogram product tangibly embodied in an information carrier, e.g., in amachine-readable storage device, for execution by a programmableprocessor; and method steps can be performed by a programmable processorexecuting a program of instructions to perform functions of thedescribed embodiments by operating on input data and generating output.The described features can be implemented advantageously in one or morecomputer programs that are executable on a programmable system includingat least one programmable processor coupled to receive data andinstructions from, and to transmit data and instructions to, a datastorage system, at least one input device, and at least one outputdevice. A computer program is a set of instructions that can be used,directly or indirectly, in a computer to perform a certain activity orbring about a certain result. A computer program can be written in anyform of programming language, including compiled or interpretedlanguages, and it can be deployed in any form, including as astand-alone program or as a module, component, subroutine, or other unitsuitable for use in a computing environment.

The terms “drug” or “medicament” are used herein to describe one or morepharmaceutically active compounds. As described below, a drug ormedicament can include at least one small or large molecule, orcombinations thereof, in various types of formulations, for thetreatment of one or more diseases. Exemplary pharmaceutically activecompounds may include small molecules; polypeptides, peptides andproteins (e.g., hormones, growth factors, antibodies, antibodyfragments, and enzymes); carbohydrates and polysaccharides; and nucleicacids, double or single stranded DNA (including naked and cDNA), RNA,antisense nucleic acids such as antisense DNA and RNA, small interferingRNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids maybe incorporated into molecular delivery systems such as vectors,plasmids, or liposomes. Mixtures of one or more of these drugs are alsocontemplated.

The term “drug delivery device” shall encompass any type of device orsystem configured to dispense a volume of a drug into a human or animalbody. The volume can typically range from about 0.5 ml to about 10 ml.Without limitation, the drug delivery device may include a syringe,needle safety system, pen injector, auto injector, large-volume device(LVD), pump, perfusion system, or other device configured forsubcutaneous, intramuscular, or intravascular delivery of the drug. Suchdevices often include a needle, wherein the needle can include a smallgauge needle (e.g., greater than about 24 gauge, and including 27, 29,or 31 gauge).

In combination with a specific drug, the presently described devices mayalso be customized in order to operate within required parameters. Forexample, within a certain time period (e.g., about 3 to about 20 secondsfor injectors, and about 5 minutes to about 60 minutes for an LVD), witha low or minimal level of discomfort, or within certain conditionsrelated to human factors, shelf-life, expiry, biocompatibility,environmental considerations, etc. Such variations can arise due tovarious factors, such as, for example, a drug ranging in viscosity fromabout 3 cP to about 50 cP.

The drug or medicament may be contained in a primary package, cartridge,or “drug container” adapted for use with a drug delivery device. Thedrug container may be, for example, a cartridge, syringe, reservoir, orother vessel configured to provide a suitable chamber for storage (e.g.,short- or long-term storage) of one or more pharmaceutically activecompounds. For example, in some embodiments, the chamber may be designedto store a drug for at least one day (e.g., 1 to at least 30 days). Insome embodiments, the chamber may be designed to store a drug for about1 month to about 2 years.

Storage may occur at room temperature (e.g., about 20° C.), orrefrigerated temperatures (e.g., from about −4° C. to about 4° C.). Insome embodiments, the drug container may be or may include adual-chamber cartridge configured to store two or more components of adrug formulation (e.g., a drug and a diluent, or two different types ofdrugs) separately, one in each chamber. In such embodiments, the twochambers of the dual-chamber cartridge may be configured to allow mixingbetween the two or more components of the drug or medicament prior toand/or during dispensing into the human or animal body. For example, thetwo chambers may be configured such that they are in fluid communicationwith each other (e.g., by way of a conduit between the two chambers) andallow mixing of the two components when desired by a user prior todispensing. Alternatively or in addition, the two chambers may beconfigured to allow mixing as the components are being dispensed intothe human or animal body.

The drug delivery devices and drugs described herein can be used for thetreatment and/or prophylaxis of many different types of disorders.Exemplary disorders include, e.g., diabetes mellitus or complicationsassociated with diabetes mellitus such as diabetic retinopathy,thromboembolism disorders such as deep vein or pulmonarythromboembolism. Further exemplary disorders are acute coronary syndrome(ACS), angina, myocardial infarction, cancer, macular degeneration,inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis.

Exemplary drugs for the treatment and/or prophylaxis of diabetesmellitus or complications associated with diabetes mellitus include aninsulin, e.g., human insulin, or a human insulin analogue or derivative,a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptoragonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4(DPP4) inhibitor, or a pharmaceutically acceptable salt or solvatethereof, or any mixture thereof. As used herein, the term “derivative”refers to any substance that is sufficiently structurally similar to theoriginal substance so as to have substantially similar functionality oractivity (e.g., therapeutic effectiveness).

Exemplary insulin analogues are Gly(A21), Arg(B31), Arg(B32) humaninsulin (insulin glargine); Lys(B3), Glu(B29) human insulin; Lys(B28),Pro(B29) human insulin; Asp(B28) human insulin; human insulin, whereinproline in position B28 is replaced by Asp, Lys, Leu, Val or Ala andwherein in position B29 Lys may be replaced by Pro; Ala(B26) humaninsulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30)human insulin.

Exemplary insulin derivatives are, for example, B29-N-myristoyl-des(B30)human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoylhuman insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) humaninsulin; B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(w-carboxyhepta-decanoyl) human insulin. Exemplary GLP-1, GLP-1analogues and GLP-1 receptor agonists are, for example:Lixisenatide/AVE0010/ZP10/Lyxumia,Exenatide/Exendin-4/Byetta/Bydureon/ITCA 650/AC-2993 (a 39 amino acidpeptide which is produced by the salivary glands of the Gila monster),Liraglutide/Victoza, Semaglutide, Taspoglutide, Syncria/Albiglutide,Dulaglutide, rExendin-4, CJC-1134-PC, PB-1023, TTP-054,Langlenatide/HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926,NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697,DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-114, BHM-034. MOD-6030,CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN andGlucagon-Xten.

An exemplary oligonucleotide is, for example: mipomersen/Kynamro, acholesterol-reducing antisense therapeutic for the treatment of familialhypercholesterolemia.

Exemplary DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin,Saxagliptin, Berberine.

Exemplary hormones include hypophysis hormones or hypothalamus hormonesor regulatory active peptides and their antagonists, such asGonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin),Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin,Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

Exemplary polysaccharides include a glucosaminoglycane, a hyaluronicacid, a heparin, a low molecular weight heparin or an ultra-lowmolecular weight heparin or a derivative thereof, or a sulphatedpolysaccharide, e.g. a poly-sulphated form of the above-mentionedpolysaccharides, and/or a pharmaceutically acceptable salt thereof. Anexample of a pharmaceutically acceptable salt of a poly-sulphated lowmolecular weight heparin is enoxaparin sodium. An example of ahyaluronic acid derivative is Hylan G-F 20/Synvisc, a sodiumhyaluronate.

The term “antibody”, as used herein, refers to an immunoglobulinmolecule or an antigen-binding portion thereof. Examples ofantigen-binding portions of immunoglobulin molecules include F(ab) andF(ab′)2 fragments, which retain the ability to bind antigen. Theantibody can be polyclonal, monoclonal, recombinant, chimeric,de-immunized or humanized, fully human, non-human, (e.g., murine), orsingle chain antibody. In some embodiments, the antibody has effectorfunction and can fix complement. In some embodiments, the antibody hasreduced or no ability to bind an Fc receptor. For example, the antibodycan be an isotype or subtype, an antibody fragment or mutant, which doesnot support binding to an Fc receptor, e.g., it has a mutagenized ordeleted Fc receptor binding region.

The terms “fragment” or “antibody fragment” refer to a polypeptidederived from an antibody polypeptide molecule (e.g., an antibody heavyand/or light chain polypeptide) that does not comprise a full-lengthantibody polypeptide, but that still comprises at least a portion of afull-length antibody polypeptide that is capable of binding to anantigen. Antibody fragments can comprise a cleaved portion of a fulllength antibody polypeptide, although the term is not limited to suchcleaved fragments. Antibody fragments that are useful in the presentdisclosure include, for example, Fab fragments, F(ab′)2 fragments, scFv(single-chain Fv) fragments, linear antibodies, monospecific ormultispecific antibody fragments such as bispecific, trispecific, andmultispecific antibodies (e.g., diabodies, triabodies, tetrabodies),minibodies, chelating recombinant antibodies, tribodies or bibodies,intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP),binding-domain immunoglobulin fusion proteins, camelized antibodies, andVHH containing antibodies. Additional examples of antigen-bindingantibody fragments are known in the art.

The terms “Complementarity-determining region” or “CDR” refer to shortpolypeptide sequences within the variable region of both heavy and lightchain polypeptides that are primarily responsible for mediating specificantigen recognition. The term “framework region” refers to amino acidsequences within the variable region of both heavy and light chainpolypeptides that are not CDR sequences, and are primarily responsiblefor maintaining correct positioning of the CDR sequences to permitantigen binding. Although the framework regions themselves typically donot directly participate in antigen binding, as is known in the art,certain residues within the framework regions of certain antibodies candirectly participate in antigen binding or can affect the ability of oneor more amino acids in CDRs to interact with antigen.

Exemplary antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

The compounds described herein may be used in pharmaceuticalformulations comprising (a) the compound(s) or pharmaceuticallyacceptable salts thereof, and (b) a pharmaceutically acceptable carrier.The compounds may also be used in pharmaceutical formulations thatinclude one or more other active pharmaceutical ingredients or inpharmaceutical formulations in which the present compound or apharmaceutically acceptable salt thereof is the only active ingredient.Accordingly, the pharmaceutical formulations of the present disclosureencompass any formulation made by admixing a compound described hereinand a pharmaceutically acceptable carrier.

Pharmaceutically acceptable salts of any drug described herein are alsocontemplated for use in drug delivery devices. Pharmaceuticallyacceptable salts are for example acid addition salts and basic salts.Acid addition salts are e.g. HCI or HBr salts. Basic salts are e.g.salts having a cation selected from an alkali or alkaline earth metal,e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), whereinR1 to R4 independently of each other mean: hydrogen, an optionallysubstituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenylgroup, an optionally substituted C6-C10-aryl group, or an optionallysubstituted C6-C10-heteroaryl group. Further examples ofpharmaceutically acceptable salts are known to those of skill in thearts.

Pharmaceutically acceptable solvates are for example hydrates oralkanolates such as methanolates or ethanolates.

The term “drug delivery device” according to instant disclosure shallmean a single-dose or multi-dose, disposable or re-useable devicedesigned to dispense a selected dose of a medicinal product, preferablymultiple selected doses, e.g. insulin, growth hormones, low molecularweight heparins, and their analogues and/or derivatives etc. Said devicemay be of any shape, e.g. compact or pen-type. Dose delivery may beprovided through a mechanical (optionally manual) or electrical drivemechanism or stored energy drive mechanism, such as a spring, etc. Doseselection may be provided through a manual mechanism or electronicmechanism. Additionally, said device may contain components designed tomonitor physiological properties such as blood glucose levels, etc.Furthermore, the said device may comprise a needle or may beneedle-free. In particular, the term “drug delivery device” shall mean adisposable multi-dose pen-type device having mechanical and manual dosedelivery and dose selection mechanisms, which is designed for regularuse by persons without formal medical training such as patients. In someinstances, the drug delivery device is of the injector-type.

The term “housing” according to instant disclosure shall preferably meanany exterior housing (“main housing”, “body”, “shell”) or interiorhousing (“insert”, “inner body”) having a helical thread. The housingmay be designed to enable the safe, correct, and comfortable handling ofthe drug delivery device or any of its mechanism. Usually, it isdesigned to house, fix, protect, guide, and/or engage with any of theinner components of the drug delivery device (e.g., the drive mechanism,cartridge, plunger, piston rod) by limiting the exposure tocontaminants, such as liquid, dust, dirt etc. In general, the housingmay be unitary or a multipart component of tubular or non-tubular shape.Usually, the exterior housing serves to house a cartridge from which anumber of doses of a medicinal product may by dispensed.

Those of skill in the art will understand that modifications (such as,for example, adjustments, additions, or removals) of various componentsof the substances, formulations, apparatuses, methods, systems, devices,and embodiments described herein may be made without departing from thefull scope and spirit of the present inventive concepts, which encompasssuch modifications and any equivalents thereof.

A number of embodiments of the present disclosure have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the presentdisclosure. Accordingly, other embodiments are within the scope of thefollowing claims.

1.-12 (canceled)
 13. An dose tracking mechanism for use in a drugdelivery device, comprising: a housing; an RFID device comprising: anelectric circuit comprising an antenna, and a switch operable to openand close the electric circuit, wherein the antenna is configured totransmit a wireless signal to a receiving device when the electriccircuit is closed by the switch, wherein the switch is configured toopen and close in response to operation of at least one of (i) a dosesetting mechanism of the drug delivery device to set a dose of amedicament, or (ii) a dose dispensing mechanism of the drug deliverydevice to dispense a dose of medicament, wherein at least one of aclosing or an opening of the electric circuit generates a pulse of thewireless signal, and wherein the switch is configured to close andsubsequently to open the electric circuit periodically during at leastone of a dose setting operation to set the dose or a dose dispensingoperation to dispense the dose, wherein the switch is operationallycoupled to a clicker mechanism having a feedback mechanism andconfigured to be operated during at least one of the dose settingoperation or the dose dispensing operation, the switch being arranged tobe actuated by the feedback mechanism, and wherein each pulsecorresponds to at least one of (i) an amount of the medicament set bythe dose setting mechanism or (ii) an amount of the medicament dispensedby the dose dispensing mechanism such that a total number of pulsesindicates a total amount of medicament.
 14. The dose tracking mechanismof claim 13, wherein the feedback mechanism is configured to produce anaudible or tactile feedback during the dose setting operation or thedose delivery operation.
 15. The dose tracking mechanism of claim 13,wherein the switch is integrally formed with the clicker mechanism. 16.The dose tracking mechanism of claim 13, wherein the dose settingmechanism or the dose dispensing mechanism comprises one or moreactuation features configured to engage the feedback mechanism toactuate the switch of the RFID device in succession during the dosesetting operation or the dose dispensing operation such that the switchcloses and subsequently opens the electric circuit to generate one pulsefor each of the one or more of actuation features that engaged thefeedback mechanism.
 17. The dose tracking mechanism of claim 16, whereinthe dose setting mechanism is configured to move proportionally to thedose set during the dose setting operation and/or the dose dispensingmechanism is configured to move proportionally to the dose dispensedduring the dose dispensing operation, and wherein the one or moreactuation features are configured to operate the switch such that theswitch generates one pulse for each step of movement of the dose settingmechanism and/or the dose dispensing mechanism such that a number of thepulses indicates the amount of the dose set or dispensed.
 18. The dosetracking mechanism of claim 16, wherein the dose setting mechanismcomprises a dose dial sleeve configured to rotate helically with respectto the housing.
 19. The dose tracking mechanism of claim 18, wherein thedose dial sleeve comprises one or more actuation features configured toengage the switch, each of the one or more of actuation featurescorresponding to a set dose indicated by the dose dial sleeve during thedose setting operation.
 20. The dose tracking mechanism of claim 13,wherein the dose dispensing mechanism comprises a piston rod configuredto move with respect to the housing during a dose dispensing operation,and wherein the dose dispensing mechanism comprises one or moreactuation features configured to engage the switch, each of the one ormore of actuation features corresponding to an amount of movement of thepiston rod.
 21. The dose tracking mechanism of claim 13, wherein theRFID device is a passive RFID device configured to transmit the wirelesssignal when RF energy is received from an external RFID reader.
 22. Thedose tracking mechanism of claim 13, comprising a power source, andwherein the RFID device is an active RFID device configured to receivepower from the power source and to transmit the wireless signal usingthe received power when the switch closes the electric circuit.
 23. Thedose tracking mechanism of claim 13, wherein the wireless signalcomprises identification information related to the drug delivery deviceor a medicament contained therein.
 24. A method for wirelessly trackingan indication of a dose injected by a drug delivery device, the methodcomprising: opening and then closing an electric circuit of an RFIDdevice once for each unit of movement of a dose dispensing mechanism ofthe drug delivery device during a dose dispensing operation or for eachunit of movement of a dose setting mechanism of the drug delivery deviceduring a dose setting operation by toggling a switch in the electriccircuit; and transmitting a pulse of a wireless signal via an antenna ofthe RFID device for each closing of the electric circuit, the RFIDdevice transmitting a number of pulses proportional to a quantity of adose of medicament set during the dose setting operation or dispensedduring the dose dispensing operation.
 25. The method of claim 24,further comprising: receiving an RF energy from an external device withthe antenna of the electric circuit and transmitting the wireless signalwith the antenna of the RFID device using the received RF energy. 26.The method of claim 24, further comprising: receiving electric energyfrom an internal power storage device with the RFID device when theelectric circuit is closed and transmitting the wireless signal with theantenna of the RFID device using the received electric energy.
 27. Themethod of claim 24, further comprising: producing an audible or tactilefeedback during the dose setting operation or the dose dispensingoperation.
 28. The method of claim 24, wherein transmitting the pulse ofthe wireless signal comprises transmitting the pulse of the wirelesssignal at a first frequency, and wherein the method further comprises:opening and then closing a second switch of the electric circuit of theRFID device when a trigger button of the drug delivery device isactivated and transmitting the wireless signal at a second frequencywhen the second switch closes the electric circuit
 29. The method ofclaim 24, wherein the dose setting mechanism comprises a dose dialsleeve, and wherein the method further comprises moving the dose dialsleeve one unit for each unit of the dose.
 30. The method of claim 29,wherein moving the dose dial sleeve one unit for each unit of the dosecomprises rotating the dose dial sleeve with respect to a housing of thedrug delivery device.
 31. The method of claim 30, wherein rotating thedose dial sleeve with respect to the housing of the drug delivery devicecomprises moving the dose dial sleeve helically with respect to thehousing.
 32. A method for wirelessly transmitting an indication of adose of a medicament delivered by a drug delivery device, the methodcomprising: moving a dose setting mechanism of the drug delivery deviceto set the dose; actuating a dose dispensing mechanism, the dosedispensing mechanism moving one unit for each unit of the dose, themoving of the dose dispensing mechanism opening and then closing aswitch of an electric circuit of an RFID device once for each unit ofmovement of the dose dispensing mechanism, the RFID device transmittinga wireless signal when the electric circuit is closed such that the RFIDdevice pulses the transmission of the wireless signal with a number ofpulses equal to the units of the dose; receiving the indication of thedose by receiving and counting the pulses of the wireless signal fromthe RFID device with an external device; and deriving an amount of themedicament delivered by counting the number of pulses.